Roche's IL-6R Monoclonal Antibody Satralizumab Nominated for Priority Review in China for NMOSD

On June 24, Roche’s marketing application in China for satralizumab, a new drug for neuromyelitis optica spectrum disorders (NMOSD), was accepted under Article 68 of the Priority Review and Approval Procedures: (1) Innovative drugs and improved new drugs that are clinically urgently needed, including those for shortages, major infectious diseases, and rare diseases, are proposed to be included in the priority review program.

Neuromyelitis Optica Spectrum Disorder (NMOSD) is a condition characterized by high relapse rates and high disability.central nervous system autoimmune disease, which was included in the National List of 121 Rare Diseases in May 2018, with a prevalence rate of approximately (1–5)/100,000 person-years. Approximately 60% of patients experience relapse within 1 year, and 90% within 3 years. The degree of disability in NMOSD patients worsens with an increasing number of relapses. Five years after disease onset, approximately 50% of patients require a wheelchair, and 62% become blind.

Satralizumab is an IL-6R monoclonal antibody that modulates multiple pathogenic processes in neuromyelitis optica spectrum disorder (NMOSD) by blocking IL-6 signaling, such as inhibiting the production of the NMOSD-specific antibody AQP4-IgG and suppressing inflammatory responses both within and outside the central nervous system. Roche has submitted marketing authorization applications for satralizumab in more than ten countries and regions worldwide, including the United States, China, and the European Union.